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Completed

NCT Number: NCT03286946

Detection of Intravascular Injection Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.

This study evaluates the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle. The investigators will performed cervical transforaminal epidural block using blunt-type block needle in half of participants or sharp-type block needle in the other half.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Radicular; Neuropathic, Cervical Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Cervical transforaminal epidural block is an effective treatment option of radiating pain. There are potential risks associated with transforaminal epidural block such as infection, dural puncture, bleeding, and intravascular injection. Although the risk is low, intravascular injection should be carefully monitored because intravascular injection of particulate steroids can cause fatal neurologic deficits such as spinal infarction and cerebral infarction.

The incidence of intravascular injection during transforaminal epidural block with real time fluoroscopy guidance depends on spinal level. The previous studies using real time fluoroscopy demonstrated that the incidence of intravascular injection of cervical transforaminal epidural block is higher than that of lumbosacral transforaminal epidural block.

In this study, therefore, the investigators investigate the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.

Exclusion criteria

  • Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

Treatment and study plan

block with Blunt-type block needle.

Procedure

Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge blunt needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.

block with sharp-type block needle.

Procedure

Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge sharp needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.

Primary outcomes

  1. Intravascular injection

    Time frame: During procedure

    Intravascular injection was defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy. The investigators observed the intravascular injection during the procedure. The intravascular injection rate was calculated based on the total number of treated levels.

Secondary outcomes

  1. Needling time

    Time frame: During procedure

    Needling time for both the sharp and blunt needles was started upon insertion of the needle through the skin and ended upon injection of contrast media under real time fluoroscopy.

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

The Difference of Intravascular Injection Rate During Cervical Transforaminal Epidural Block Using Blunt-type Block Needle Compared to Sharp-type Block Needle.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2017
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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